CAI Overview

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About Us

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

About the Role

We are hiring a CQV Downstream Lead to manage commissioning and qualification activities across downstream process systems on a major biopharmaceutical manufacturing project.

This is a high-visibility leadership role where you will own downstream CQV delivery from system design review and risk assessment through execution, qualification (IQ/OQ/PQ), and handover to Operations.

Responsibilities

Lead end-to-end CQV for downstream systems (design, IQ/OQ/PQ, handover)
Own downstream technologies: chromatography, UF/DF/TFF, filtration, CIP/SIP
Drive system readiness: walkdowns, punch lists, FAT/SAT, startup
Execute risk-based CQV strategy (GMP, Annex 15, ASTM E2500)
Lead IQ/OQ/PQ execution and ensure right-first-time delivery
Oversee CQV documentation (plans, risk, protocols, reports)
Manage deviations, change control, CAPAs, inspection readiness
Coordinate across Engineering, QA, Automation, Ops, Vendors
Lead and mentor CQV team members

Requirements

Degree in Engineering, Biotechnology, or related
7+ years CQV experience in biopharma (strong downstream focus
Experience with CQV documentation, deviations, change control
Strong stakeholder and on-site leadership skills

Preferred

Experience leading CQV on large capital projects
Knowledge of downstream purification (capture, polish, viral filtration)
Exposure to single-use systems, skids, or automation interfaces
Experience supporting audits / inspections / operational readiness

What’s In It For You

Lead high-impact downstream CQV delivery on a flagship biologics project
Work with cutting-edge purification technologies and systems
Join a high-performing CQV team on complex, large-scale builds
Gain strong visibility with clients and senior project stakeholders
Exposure to end-to-end project lifecycle

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CQV Downstream Lead

Job Description